FDA Approves New Indication for Wyeth's TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia Indication
Offers New Option for Adult Patients Suffering From Community-Acquired Bacterial Pneumonia
COLLEGEVILLE, Pa., March 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the U.S. Food and Drug Administration (FDA) approved TYG...
Catalyst to Focus Resources on its Lead Indication for CPP-109; Cocaine Addiction
CORAL GABLES, Fla., March 3 /PRNewswire/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX ), a biopharmaceutical company that acquires or in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction, today announced modifications to its previously announ...
Nostrum Pharmaceuticals Obtains Worldwide Licensing Rights From IMTECH for Clinical Development of the Small Molecule Caerulomycin and Its Proprietary Derivatives for Their Novel Indication of Immunosuppression
EDISON, N.J., Feb. 23 /PRNewswire/ -- Nostrum Pharmaceuticals, LLC ("Nostrum"), a privately-held company based in Edison, New Jersey, announced today that it has obtained a worldwide license to develop and commercialize Caerulomycin A, and its proprietary derivatives and analogues ("Caerulomycin")...
FDA Approves Low-dose Regimen of PREMARIN Vaginal Cream to Treat Moderate to Severe Postmenopausal Dyspareunia – Painful Sexual Intercourse : Agency Grants New Indication for Bothersome Vaginal Symptom Associated with Menopause
PREMARIN (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication
and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmac...
FDA Approves New Indication for Hospira's Precedex (Dexmedetomidine HCL) Injection
- Expands Therapy to Broader Patient Population -
LAKE FOREST, Ill., Oct. 30 /PRNewswire-FirstCall/ -- Hospira, Inc.
(NYSE: HSP ), a global specialty pharmaceutical and medication delivery
company, announced today that the U.S. Food and Drug Administration (FDA)
approved a new indi...
FDA Extends Review Timeline for Additional Indication for Antibiotic DORIBAX(TM)
RARITAN, N.J., March 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical
Research & Development, L.L.C., today announced that the U.S. Food and Drug
Administration (FDA) has extended the review timeline for the second New
Drug Application for the antibiotic DORIBAX(TM) (doripenem for injection)...
FDA Approves Additional Indication for Astellas' MYCAMINE(R)
DEERFIELD, Ill., Jan. 23 /PRNewswire/ -- Astellas Pharma Inc. announced
today that the U.S. Food and Drug Administration (FDA) has approved their
Supplemental New Drug Application (sNDA) seeking approval for the use of
MYCAMINE(R) (micafungin sodium) for Injection in the treatment of patients
Duramed Launches New Indication for ENJUVIA(TM) (Synthetic Conjugated Estrogens, B) at North American Menopause Society Annual Meeting
WOODCLIFF LAKE, N.J., Oct. 2 /PRNewswire-FirstCall/ -- Duramed
Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc. (NYSE:
BRL), announced today the launch of its marketing campaign for ENJUVIA(TM)
for the treatment of moderate-to-severe vaginal dryness and pain with
BUSM researchers find no adjustment method fully resolves confounding by indication
(Boston) - Researchers at Boston University School of Medicine (BUSM) and Boston University School of Public Health have found that no adjustment method fully resolves confounding by indication
in observational studies, meaning when the validity of a study is threatened by unmeasured confounding, ...
Early Arctic Spring Indication of Climate Change
Spring in the Arctic has been registered weeks earlier than a decade ago and is likely linked to climate warming, a team of researchers said .
"Despite uncertainties in the magnitude of expected global warming over the next century, one consistent feature of extant and projected changes is ...
Hiccups May Be An Indication Of Esophageal Cancer
According to an Irish researcher, frequent hiccups together with weight loss and difficulty in swallowing may be an indication
of esophageal cancer. //
Professor Tom Walsh, author of the report, from the James Connolly Memorial Hospital in Dublin, told a meeting of the Royal College of Surgeo...
Plavix Gets FDA Okay for New Indication
The antiplatelet medication Plavix (clopidogrel bisulfate) received US Food and Drug Administration approval for use in acute coronary syndrome. People with acute coronary syndrome are at high risk for heart attack, typically because they have unstable angina, or heart disease-related chest pain. A...
US Oncology Reports Second Quarter Operating Results
... Services ("CMS") establishing criteria for reimbursement by Medicare for the ESA usage issued on July 30, 2007. Unlike the NCD from CMS, the label indication
directs appropriate physician prescribing and applies to all patients and payers. A Risk Evaluation and Mitigation Strategy ("REMS") proposal by manu...
Transcept Pharmaceuticals to Report Second Quarter 2009 Results
...tainties, including, but not limited to, whether FDA determines that the Intermezzo (R) NDA is sufficient to approve Intermezzo (R) for its intended indication
and any delays in, and the final form of, any FDA approval of Intermezzo (R); the commercial success of Intermezzo (R), if approved; physician or p...
BioMed Realty Trust Commemorates Five-Year Anniversary as a Public Company
... And while we remain very cautious with respect to the current leasing environment, the recent capital raising successes from our tenants serve as an indication
that the primary mechanisms for funding the life science industry appear to be functioning effectively. In particular we note the continuing critical...
The Advisory Board Company Reports Fiscal Year 2010 First Quarter Results
...ns and results may differ materially from the results discussed in the forward-looking statements, and reported results should not be considered as an indication
of future performance. Factors that could cause actual results to differ materially from those indicated by forward-looking statements include, among...
Clarient Reports Second Quarter Revenue Up 40 Percent
...balance sheet. In addition, we collected $19.9 million in cash in the second quarter which is a 34% increase over our first quarter. This is a strong indication
that our billing and collection process is improving."
Land cited continued progress in marketing programs and customer retention, combined wit...
Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers
...d movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication
for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performa...
CCHRINT Announces FDA Reported Psychiatric Drug Side Effects Search Engine
...t reporting systems, including the drug name, demographics, adverse reactions, patient outcomes, reporting source, therapy start and end dates and the indication
(diagnosis). The result: A database and search engine that unravels the 94,000 pages of codified psychiatric drug adverse reactions reported each ye...
Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations
...BIBW 2992 entered Phase IIb/III clinical development in NSCLC earlier in 2008 and was granted Fast Track designation for a third/fourth line treatment indication
in NSCLC by the US Food & Drug Administration. In addition, the LUME-Lung Phase III clinical trial program, which is investigating BIBF 1120 in co...
HIV integrase inhibitor effective for patients beginning antiretroviral treatment
...or people infected with HIV that is resistant to other drugs. The results of this study contributed to the July 2009 decision by the FDA to expand the indication
for raltegravir beyond only individuals infected with HIV that is resistant to other drugs.
INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder
...sseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development. "This new indication
for INVEGA(R) further demonstrates Janssen's commitment to helping people with serious mental illnesses."
Please see the Important Safety Infor...
Cancer treatment controls macular edema related to diabetes and to cataract surgery
...apy may prove useful." He added, "Also, once further study is completed, unresolved CME post-cataract surgery should be considered for inclusion as an indication
for use of IVB." "
Extra Precautions Needed with Cataract Surgery for DR Patients
Before 1996, retinopathy often developed or progressed rapidly...
ER Visits Mostly by Medicare, Medicaid Recipients
...-release" rate for uninsured patients was 421 visits per 1,000 people, compared with 301 visits per 1,000 for those with insurance. This is a possible indication
that people without insurance use hospital emergency departments as their usual source of care.
The study is based on an analysis of data from the...
Boot Camp for New Dads Now Working with Renowned Katherine Stone - Educating Fathers about Postpartum Depression
... day and/or more than once a day is a red flag. Disinterest -- When mom is not interested in herself, her baby, family or other activities, it's an indication
that something is wrong. Mood swings - Similar to a roller coaster ride, mood swings are extreme changes in mood. Mom's joyfulness immediately fol...
ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
... conduct future studies with maribavir, and the timing and potential outcomes of the review of our regulatory submission related to an acute treatment indication
We plan to remain vigorous in our opposition to any bioequivalence approach considered for use in approving generic formulations o...
Ethicon Endo-Surgery Holds Metabolic Surgery Scientific Forum Featuring Research By Top Scientists
... depending on the surgical procedure."
"Diabetes is a chronic progressive disease," said Dr. Schauer. "BMI is easy to measure and a pretty good indication
of the percentage of body fat, so we should just use it as a marker but not a rule."
About Ethicon Endo-Surgery
Ethicon Endo-Surgery, Inc....
Viagra Trial for Sickle Cell Lung Problems Halted
...derate pulmonary hypertension."
The investigators don't know why the trial produced the increased risk for pain crises, but they said there was no indication
that the drug is not safe in other populations.
Pfizer, which makes Viagra and Revatio, provided the drug as well as the placebo for the trial.
Paradigm Spine Closes $21.5 Million Financing and Announces Promotion of Matt Stuttle to Position of Vice President, US Sales
...and diseases. The company's mission is to provide only "Best in Class" products and services to Spine Surgeons and to be above all, "Surgeon Centric, indication
Specific and Data Driven".
The company is concentrating on building a multi-product non-fusion portfolio. The company's signature product is th...
With Autism, Diet Restrictions May Do More Harm Than Good
...artment at Texas A&M Health Science Center College of Medicine, said he thought "the really interesting thing they found was that there wasn't any indication
of celiac disease."
In the group studied, the researchers found just one case. A possible link between celiac disease and autism was proposed as fa...
Leading health organizations launch new accreditation process for laboratories across Africa
... poorly resourced facilities anywhere.
If laboratories function properly, doctors and nurses will not only get correct diagnoses of diseases and an indication
of when and how to begin treatment, but they will also know when drugs fail and when people develop resistance to medications. This is a critical comp...
FDA Approves Expanded Use of Lilly's FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis
...ersity of Alabama in Birmingham. "The approval of teriparatide for this new indication
offers healthcare providers and patients a new treatment option that effect...ent way than anti-resorptives."
Since this new indication
extends the use of FORTEO to patients with GIO who may be younger than thos...
Universal Health Realty Income Trust Reports 2009 Second Quarter Financial Results
...AP and should not be considered to be an alternative to net income determined in accordance with GAAP. In addition, FFO should not be used as: (i) an indication
of our financial performance determined in accordance with GAAP; (ii) an alternative to cash flow from operating activities determined in accordance w...
Transcept Pharmaceuticals to Present at BMO Capital Markets Healthcare Conference on August 5, 2009
...tainties, including, but not limited to, whether FDA determines that the Intermezzo(R) NDA is sufficient to approve Intermezzo(R) for its intended indication
and any delays in, and the final form of, any FDA approval of Intermezzo(R) ; the ability of Transcept to commercialize Intermezzo(R) effectively, ...
Roche Cardiac 200 Offers Rapid Cardiac Diagnostics for the Point of Care
...artment (ED) with symptoms of a cardiovascular event are typically tested for a series of "cardiac markers," or chemicals that the body releases as an indication
of recent heart damage or potential cardiovascular problems. Often the ED physicians treating these patients cannot afford to wait for traditional tes...
The Friendship Stone Helps Friends Remain Healthy
...squo;s life. Our goals are high, but this Friendship Week we hope to reduce the number of lonely people in our country. If everyone would give a small indication
of their faith in one other person, we are sure there would be many more, happier, healthier people.”
The week will be filled with activiti...
Tips from the journals of the American Society for Microbiology
...ceiving a single shot of the Iscomatrix adjuvant vaccine displayed fewer signs of infection and remained highly active.
"Our data provide the first indication
that in the event of a future influenza pandemic, effective mass vaccination may be achievable with a low-dose 'single shot' vaccine and provide not o...
AlphaRx Unveils its China Strategy
...an injectable nanoemulsion, in collaboration with Gaia BioPharma for the treatment of acute hepatitis, a therapy with a multi-million dollar potential indication
The Chinese government has been a strong supporter of the life sciences industry. It plans to further increase its investment in the secto...
Boston Scientific Announces Results for Second Quarter Ended June 30, 2009
...erte((R)) Atom(TM) Paclitaxel-Eluting Coronary Stent System, the TAXUS((R)) Liberte((R)) Long Paclitaxel-Eluting Coronary Stent System and an expanded indication
for the SpyScope((R)) Access and Delivery Catheter, as well as CE Mark for the ENDOTAK RELIANCE((R)) 4-SITE Defibrillation Lead System and the LATITUD...
96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy
...treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.
is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically adva...